Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT02514434
Eligibility Criteria:
Inclusion Criteria:
* Male or female subject between 20 and 70 years of age at the time of randomization
* Has chronic liver disease with compensated liver cirrhosis (Child-Pugh score A), defined as 1) histologically confirmed cirrhosis, or 2) has chronic liver disease and shows the presence of splenomegaly or other typical findings of liver cirrhosis on ultrasonography, computed tomography, or magnetic resonance imaging, or 3) has chronic liver disease and shows the presence of endoscopically-confirmed esophageal or gastric varices
* Absence of severe cardiovascular, pulmonary, renal or infectious diseases, other than chronic liver disease
* Absence of a history of malignancy within previous 5 years
* Can and will comply with the requirements of the protocol (e.g. return for follow-up visits), in the opinion of the investigator
* Has provided written informed consent
Exclusion Criteria:
* Greater than 70 years of age
* Presence of liver cancer or other intrahepatic malignancy
* Has a history of malignancy within previous 5 years
* Is pregnant or breast-feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT02514434
Study Brief:
Protocol Section:
NCT02514434